Director of Regulatory and Clinical Affairs
3 weeks ago
Renata Medical is seeking an experienced and organized leader to guide and develop global clinical and regulatory activities for pre- and post-approval pediatric cardiovascular medical devices. This role is responsible for developing and leading the strategic plans for regulatory approvals, providing interpretation of regulatory guidelines, leading all regulatory submissions, and managing resources to execute clinical trials. This candidate will work in a cross-functional setting, work on project teams and manage employees to help resolve the complex issues of gaining approval for sale across the globe while obtaining a deep clinical understanding of congenital heart diseases. This candidate will report directly to the CEO and will play a pivotal role in driving strategic initiatives and working with the leadership team. Renata is a fast-paced startup company that will rely on a motivated, resilient candidate able to work with a small team, embrace new challenges, and execute at a high level in a team setting.
Education and/or Work Experience Requirements
· Bachelor’s degree
· 6+ years of experience in Regulatory/Clinical experience
· Deep knowledge of US FDA Class III Medical Device Guidelines
· Strong knowledge of Class III medical devices and relevant international regulations
· Excellent written and verbal skills
· High attention to detail
· Knowledge of Quality system requirements
Benefits
· Health insurance
· Dental insurance
· Paid time off
· Vision insurance
· Stock options
Supplemental Pay
· Bonus pay
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